Composition comprising estrogen-cyclodextrin complex, unit dosage form containing thereof, method for the preparation of composition, method for improving stability of estrogen in composition and use of estrogen-cyclodextrin complex

摘要

A composition comprising i) estrogen-cyclodextrin complex in a granulate preparation, wherein when the granulate preparation comprises polyvinylpyrrolidone, it is present in a concentration of at the most 2 % w/w; and optionally ii) one or more excipients, wherein the composition has a stability such that said estrogen is in amount of at least 85 % w/w in relation to the initial content of said estrogen after storage for 12 months at 40 °C and 75 % relative humidity, and it is suitable as contraceptive or a medicament for female hormone replacement therapy. Described is also unit dosage form containing thereof, a method for the preparation of the composition, a method for improving the stability of estrogen in the composition and use of estrogen-cyclodextrin complex.